One of the most crucial factors directly influencing the validity of a laboratory diagnostic test is the proper transport of the clinical specimen to the site where the test will be conducted. Thus, the active components of a test sample must be preserved for a sufficient length of time to permit credence to be taken of any test result. In short, a laboratory test result can only be as good as the integrity of the specimen examined.
Laboratory and field studies have indicated that, in many instances, the effective activity of components in a clinical specimen decreases precipitously, when exposed to the ambient environment, both at room temperatures and at low temperatures. For example, Table I reports experimental studies on an enzymatic test for the detection of Neisseria gonorrhoeae which indicated that enzymatic activity in gonococcal lysates could be essentially lost after 24 hours. Consequently, there has been a need for an efficient transport system which stabilizes and/or preserves the enzymatic activity during movement of clinical specimens.
TABLE I ______________________________________ Instability of Enzymatic Activity in Lysates Stored on Cotton-Tipped Swabs % Enzyme Activity Lost After Storage Temp. .degree. C. 24 hours 48 hours 72 hours ______________________________________ 25 98 99 100 -20 89 95 100 ______________________________________
The instant invention is designed to provide such a system and is particularly described with reference to the test for Neisseria gonorrhoeae disclosed in the above-cited patent application Ser. No. 837,366, entitled "Detecting Neisseria Bacteria".